BACKGROUND: In a multicentre clinical study was evaluated the efficacy and safety of a mouthwash containing diclofenac 0.074% in patients undergone to oral or periodontal surgery. METHODS: Multicentre clinical open study. The patients rinsed for 1 min twice a day with diclofenac mouthwash for 7 days. After the baseline measurements of all parameters, spontaneous pain and burning were evaluated daily, while redness and oedema after 3 and 7 days of treatment. Seventy-nine patients (48 F, 31 M), mean aged 42.5 years+/-13.1 SD, with pain intensity at the end of anaesthesia effect equivalent to 54.8 mm+/-15.1 SD of a visual analogue scale were evaluated for efficacy. RESULTS: Spontaneous pain was significantly reduced by diclofenac mouthwash, versus baseline, in the first day of treatment. After a week of treatment, intensity was reduced more than 88% (p<0.01). Burning, redness and oedema too evidenced a similar behaviour, with absence of the sign respectively superior to 87%, 72% and 91 % (p<0.01). The physician's and patient's final judgement overlapped, recording a resolution/improvement in 94.1% of cases, particularly improvement in 77.2% for the physician and in 70.9% for the patients. Palatability was judged pleasant/acceptable in all cases. CONCLUSIONS: Diclofenac mouthwash is endowed by very good efficacy and safety in the treatment of inflammatory condition of the buccal cavity following oral or periodontal surgery.
BACKGROUND: In a multicentre clinical study was evaluated the efficacy and safety of a mouthwash containing diclofenac 0.074% in patients undergone to oral or periodontal surgery. METHODS: Multicentre clinical open study. The patients rinsed for 1 min twice a day with diclofenac mouthwash for 7 days. After the baseline measurements of all parameters, spontaneous pain and burning were evaluated daily, while redness and oedema after 3 and 7 days of treatment. Seventy-nine patients (48 F, 31 M), mean aged 42.5 years+/-13.1 SD, with pain intensity at the end of anaesthesia effect equivalent to 54.8 mm+/-15.1 SD of a visual analogue scale were evaluated for efficacy. RESULTS: Spontaneous pain was significantly reduced by diclofenac mouthwash, versus baseline, in the first day of treatment. After a week of treatment, intensity was reduced more than 88% (p<0.01). Burning, redness and oedema too evidenced a similar behaviour, with absence of the sign respectively superior to 87%, 72% and 91 % (p<0.01). The physician's and patient's final judgement overlapped, recording a resolution/improvement in 94.1% of cases, particularly improvement in 77.2% for the physician and in 70.9% for the patients. Palatability was judged pleasant/acceptable in all cases. CONCLUSIONS:Diclofenac mouthwash is endowed by very good efficacy and safety in the treatment of inflammatory condition of the buccal cavity following oral or periodontal surgery.